Study Design: a Phase II, single-arm, multicenter, prospective, interventional study.
Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation.
Treatment Regimen: All enrolled subjects will receive IBI351 combined with cetuximab β injection. Treatment will continue until disease progression (as assessed by the investigator per RECIST 1.1 criteria) or the occurrence of intolerable toxicity.
Primary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Secondary Endpoints: Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), and Overall Survival (OS) , and safety.
Voluntarily participate in the study and sign the informed consent form (ICF).
Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF.
Life expectancy ≥ 3 months.
Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC), per the International Association for the Study of Lung Cancer (IASLC) and American Joint Committee on Cancer (AJCC) 8th edition TNM staging, and not candidates for curative concurrent chemoradiotherapy.
Histologically or cytologically confirmed NSCLC with mixed small cell components or predominantly squamous cell carcinoma components.
Presence of EGFR sensitizing mutation, ALK rearrangement, ROS-1 fusion, or other genomic alterations for which NMPA-approved first-line NSCLC therapies exist.
Active infection requiring systemic therapy.
Baseline positive HIV antibody (HIV-Ab); acute or chronic active hepatitis B (defined as HBsAg and/or HBcAb positive AND HBV-DNA > 2500 copies/mL or 500 IU/mL); or acute or chronic active hepatitis C (HCV antibody positive AND HCV-RNA above the lower limit of quantification).
Single group
IBI351 combined with cetuximab β
DrugSubjects will receive treatment with IBI351 plus cetuximab β, consisting of oral IBI351 administered at 600 mg twice daily (BID) either in a fasting or fed state, combined with intravenous infusion of cetuximab β injection dosed at 500 mg/m² (body surface area) every two weeks. Each treatment cycle spans two weeks. Therapy will continue until disease progression, unacceptable toxicity, or meeting other protocol-defined criteria for treatment discontinuation-whichever occurs first. Dose adjustments may be implemented throughout the study based on drug-related toxicities.
Objective Response Rate
The proportion of patients achieving complete and partial response after treatment, measured according to RECIST v1.1 criteria
Progression-Free Survival
Progression-free survival is defined as the time from first dose of treatment to the first documentation of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1 criteria
Time To Response
Time from the first administration of the drug to the first assessment by the investigator using RECIST 1.1 criteria as Complete Response or Partial Response
Disease Control Rate
Disease control rate is defined as the proportion of participants with complete response, partial response, and stable disease, as determined by RECIST v1.1 criteria
Overall Survival
The time from the first administration of treatment to death due to any reason
Click on the lead sponsor to view all of their trials.
Guangdong Association of Clinical Trials
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
Mabpharm Limitied
Collaborator
